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Session 6 Track A & B: Evaluation of Intrinsic Factors/Organ Impairment Studies and of Extrinsic Factors/Drug-Drug Interaction Liability
Session Chair(s)
Hobart Rogers, PharmD, PhD
Pharmacologist
FDA, United States
Gabriel J. Robbie, PhD
Senior Vice President, Clinical Pharmacology and Pharmacometrics
Alnylam Pharmaceuticals, Inc., United States
Oligonucleotide therapeutics have unique characteristics that often require differential pre-clinical and clinical assessment compared to small molecules. This session will address two of these topics: Topic One will focus on the evaluation of both renal and hepatic impairment; Topic Two will focus on the assessment of drug-drug interactions liability with oligonucleotides. Both topics will have perspective presentations from industry and regulatory speakers. Following the presentations, a joint panel will convene to further discuss these topics with implications for guiding future regulatory oversight.
Speaker(s)
FDA Evaluation of Renal/Hepatic Impairment
Martina Sahre, PhD
FDA, United States
Staff Fellow
Evaluation of Renal/Hepatic Impairment on the Pharmacokinetics of Antisense Oligonucleotides
Yanfeng Wang, PhD
Ionis Pharmaceuticals, United States
Executive Director
Evaluation of Oligonucleotide Therapeutics in Patients with Renal and Hepatic Impairment
Bahru Habtemariam, PharmD
Alnylam Pharmaceuticals, United States
Senior Director, Clinical Pharmacology
Panel Discussion
Panel Discussion
All Session Speakers, United States
Evaluation of Extrinsic Factors/Drug-Drug Interaction Liability In Vitro
Oluseyi Adeniyi, PharmD, PhD
FDA, CDER, United States
Reviewer
In Vitro/In Vivo
Faraz Kazmi, PhD
Janssen Research & Development, United States
Senior Scientist, Drug Metabolism and Pharmacokinetics (DMPK)
Evaluating Clinical Drug Interactions for Oligonucleotide Therapeutics
Venkateswaran Chithambarampillai, PhD, MS
CDER, FDA, United States
Senior Staff Fellow, Office of Clinical Pharmacology
Panel Discussion
Panel Discussion
All Session Speakers, United States